Documenting sample quality: the Standard PREanalytical Code Version 3.0

Ensuring the traceability and documentation of the preanalytical phase is an important aspect when it comes to assessing the quality and fitness-for-purpose of biological samples. The newly-released Standard PREanalytical Code Version 3.0 (SPREC v3.0) is a tool that helps keep a record on the variables that affect specimens prior to their downstream analysis.

Precision preanalytics has been recognised as a key prerequisite for the widespread development and success of precision medicine. Unknown or uncontrolled preanalytical variables – parameters that affect the specimen prior to its analysis – can have negative repercussions on the accuracy and reproducibility of downstream analytical results, thus potentially compromising the sample’s fitness for purpose. For this reason, quality assurance related to pre-analytical workflows – i.e. the collection, processing and storage of biospecimen – is increasingly being addressed by international standards. Major steps in this direction have been taken by the Biospecimen Science Working Group of the International Society for Biological and Environmental Repositories (ISBER BSWG), co-chaired by IBBL’s Chief Scientific Officer Dr. Fay Betsou, which has been working assiduously towards the standardisation of biobanking activities.

Indeed, in February 2018, the ISBER BSWG published the third updated version of the Standard PREanalyticalCode (SPREC v3.0), a tool initially developed in 2009 that allows biobanks to manage and track the most important pre-analytical variations.

Specifically, the SPREC code is composed of seven individual elements, characterising seven variables. In the case of liquid samples, these are sample type, primary container type, pre-centrifugation conditions (i.e. the delay between collection and processing and the temperature), first centrifugation time/speed/temperature, second centrifugation time/speed/temperature, post-centrifugation and long-term storage conditions. For solid samples, the seven critical variables are sample type, collection type (e.g. autopsy, biopsy, etc.), warm ischemia time, cold ischemia time, fixation/stabilisation type, fixation time and long-term storage conditions.

The SPREC v3.0 introduces additional options under each of the seven variables, compared to the previous SPREC v2.0, based on the latest technological developments and recently acquired knowledge on the critical ranges of preanalytical times, such as tissue ischemia times.

“Contributing to devising and periodically updating the SPREC tool is part of IBBL’s ongoing efforts to ensure the quality and fitness for purpose of biological samples”, comments Dr. Betsou, corresponding author of the SPREC v3.0 publication. “IBBL’s activities in this area span from the identification of biomarkers to diagnose the quality of specimens, to the standardisation of pre-analytical workflows as part of an EU-funded consortium and the contribution to the development of international biobanking technical standards through close cooperation with the international community”.

The SPREC v3.0 was published in the journal ‘Biopreservation and Biobanking’ and can be accessed here. It will be available on the ISBER website shortly.